{"id":317,"date":"2026-04-20T16:59:18","date_gmt":"2026-04-20T16:59:18","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=317"},"modified":"2026-04-20T16:59:18","modified_gmt":"2026-04-20T16:59:18","slug":"omufa-fy-2026","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2026\/04\/20\/omufa-fy-2026\/","title":{"rendered":"OMUFA FY 2026"},"content":{"rendered":"\n

The\nOTC Monograph drug user fee program (OMUFA)<\/a> is the user fee paid by OTC\nmonograph drug manufacturers and contract manufacturers.<\/p>\n\n\n\n

OTC Monograph drug facility is defined as a foreign or\ndomestic establishment that satisfies the requirements below.<\/p>\n\n\n\n

  1. Under one management and at one geographic\nlocation that manufactures or process finished dosage form of an OTC monograph drug<\/a><\/li>
  2. It also includes the finished dosage form of the\ndrugs manufactured under contract.<\/li>
  3. It does not include the drug used for clinical\nresearch supplies, testing, and creating multiple packing.<\/li><\/ol>\n\n\n\n

    OTC\nMonograph Drug<\/a> facilities registered with FDA from January 1, 2025, through\nDecember 31, 2025, are liable for the FY 2026 FDA fees.<\/p>\n\n\n\n
    \n Type of Registration \/\n Application<\/strong>\n <\/td>\n MDF Facility<\/strong>\n <\/td>\n CMO Facility<\/strong>\n <\/td><\/tr>
    \n OTC Monograph Drug Facility\n (OMUFA) Fee\n <\/td>\n $19,188<\/strong>\n <\/td>\n $12,792<\/strong>\n <\/td><\/tr><\/tbody><\/table>\n\n\n\n

    FDA will send invoices to establishment directly and the\nfees must be paid within 20 calendar days of the original due date. Failure to\ndo so will result in following.<\/p>\n\n\n\n

    1. Establishment name will be published on FDA\npublicly available arrear list.<\/li>
    2. OTC monographs drug manufactured in such\nfacility will be considered misbranded.<\/li>
    3. OTC monographs order request submitted by a\nperson will not be accepted for filings until all fees that are due will be\npaid fully.<\/li>
    4. Person who owes the fees to FDA shall be\nconsidered ineligible for OTC monograph drug meetings until they pay the fee in\nfull.<\/li><\/ol>\n\n\n\n

      As part of the transition in FY 2027, facility fees will be\nassessed in two installments: 50 percent will be due on October 1, 2026, and\nthe remaining 50 percent will be due on February 1, 2027.<\/p>\n\n\n\n

      Liberty Management Group Ltd, a leading FDA consulting group provides assistance with OMUFA<\/a> PIN creation, API drug establishment registration<\/a>, Drug establishment registration and listing renewals<\/a> and US agent service to foreign countries.<\/a><\/p>\n\n\n\n

      Sudha S<\/p>\n\n\n\n

      Regulatory Consultant<\/p>\n\n\n\n

      Email: Office@libertymanagement.us<\/p>\n\n\n\n

      www.fdahelp.us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

      The OTC Monograph drug user fee program (OMUFA) is the user fee paid by OTC monograph drug manufacturers and contract manufacturers. OTC Monograph drug facility is defined as a foreign or domestic establishment that satisfies the requirements below. Under one management and at one geographic location that manufactures or process finished dosage form of an … Continue reading “OMUFA FY 2026”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26],"tags":[47],"class_list":["post-317","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","tag-fda-omufa-fees"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/317","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=317"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/317\/revisions"}],"predecessor-version":[{"id":318,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/317\/revisions\/318"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=317"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=317"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=317"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}